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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VACCESS PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. VACCESS PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number VA8094
Device Problems Deflation Problem (1149); Retraction Problem (1536)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/09/2021
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 03/2023).
 
Event Description
It was reported that during an angioplasty procedure through left upper arm, the device allegedly failed to deflate.It was further reported that the balloon allegedly had retraction issue so the physician performed a cutdown to remove the balloon and sheath.The procedure was completed using another device.The patient current status is unknown.
 
Manufacturer Narrative
H10: manufacturing review: a device history record review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one device was returned for evaluation.The device was noted to still be loaded into a sheath with the distal end buckled.The device was then successfully flushed and inserted with an in house syringe and guidewire respectively.An in house presto device was used to inflate the device to nominal pressure, the balloon was noted to maintain uniform shape and pressure.The balloon was then deflated without issues and the deflation time was in spec with pps-8070.However, the device had difficulty being retracted through the sheath and bunching was noted to be forming at the proximal end.Therefore the alleged failure deflate can be unconfirmed for, as the balloon was able to be inflated and deflated without issues during evaluation.The investigation is confirmed for the retraction issue, as the device was noted to have resistance and buckling was noted when device was retracted through the sheath during evaluation.The reported deflation issue most likely contributed to the reported retraction issue.However, the definitive root cause for the reported deflation and retraction issue could not be determined.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 03/2023).H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.
 
Event Description
It was reported that during an angioplasty procedure through left upper arm, the device allegedly failed to deflate.It was further reported that the balloon allegedly had retraction issue so the physician performed a cutdown to remove the balloon and sheath.The procedure was completed using another device.The patient current status is unknown.
 
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Brand Name
VACCESS PTA DILATATION CATHETER
Type of Device
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key11612975
MDR Text Key246377771
Report Number2020394-2021-00780
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00801741121357
UDI-Public(01)00801741121357
Combination Product (y/n)N
PMA/PMN Number
K111850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVA8094
Device Catalogue NumberVA8094
Device Lot Number93QE0025
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2021
Date Manufacturer Received05/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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